Prostatic Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)

Not Applicable

Withdrawn

• Conditions: Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

• Registration Number: NCT04563221
• Lead Sponsor: Andrew Picel

Brief Summary

This is a single center, prospective, investigational study to evaluate the safety and efficacy of prostatic artery embolization (PAE) for the treatment of moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Embolization will be performed with LC Bead LUMI particles using a balloon occlusion microcatheter or standard microcatheter.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-20
• Study First Submitted QC: 2020-09-20
• Study First Posted: 2020-09-24
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-26
• Last Update Posted: 2021-10-04
• Study Start: 2022-05-01
• Primary Completion: 2023-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Age ≥ 45 years and ≤ 85 years old
• Prostate volume ≥ 40 mL and ≤ 300 mL
• Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS)
• Refractory or intolerant to medical management
• Ineligibility for or refusal of surgical management
• No evidence of prostate cancer

Exclusion Criteria

• History of pelvic cancer
• Neurogenic bladder disorder
• Bladder diverticula greater than 5 cm or bladder stones
• Acute urinary retention with Foley catheter dependence
• Active urinary tract infection, interstitial cystitis, or prostatitis within the last 3 months
• Prior surgical prostate intervention
• Active participation in another clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of patients with treatment related adverse events assessed by CTCAE v4.0.	12 months post PAE
Mean change from baseline in symptom score using the IPSS scale at 6 months	Baseline and 6 months post PAE

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in Qmax (maximum urinary flow)	Baseline, 6 months and 12 months post PAE
Mean change from baseline in PVR (post void residual)	Baseline, 6 months and 12 months post PAE
Mean change from baseline in prostate volume	Baseline, 6 months and 12 months post PAE
Mean change from baseline in IPSS to measure long-terms subjective outcome	Baseline, 12 and 24 months post PAE

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States